Umbilical cord blood is an up-and-coming and readily-available source of transplantable hematopoietic stem cells unhindered by ethical issues or complex surgical extraction. It is collected from the umbilical cord and placenta after birth and used in the treatment of over 70 diseases, offering improved outcomes and replacing other graft sources when applicable. There are over 670 ongoing clinical trials examining potential cord blood therapies that collectively affect over 300 million people worldwide.
Currently, cord blood is banked privately, as fee-for-service, and publicly, similar to blood donations. Despite its potential, cord blood experiences limited adoption, and over 90% of cord blood in the US is discarded. One of the primary reasons for its underutilization is the ineffective collection method; the conventional, gravity-driven needle and blood bag is inefficient, highly dependent on user skill and patience, and consistently fails to collect sufficient quantities of cord blood stem cells. Because clinical outcomes are driven by cell dose per patient body weight, 60% of 2010's estimated 100,000 cord blood units (CBUs) collected for US public banking were discarded, as they did not contain enough total nucleated cells (TNC) to be deemed clinically relevant. Even banked units are almost always limited to pediatric therapies, with less than 10% of the banked inventory able to treat an adult of 150 lb. at the minimum recommended cell dose of 2.5×107 TNC/kg. Yet, over 90% of disease occurrence treated with cord blood takes place in adulthood.
These low cell yields have adversely affected the industry. Public banks operate by absorbing the costs of collection and processing ($425/unit) to store a CBU and sell it for an average of $35,000 for a transplant procedure. Public banks, however, struggle with unsustainable costs of an effective $122,000 per CBU sold, associated with banking unsellable (due to low TNC) units in the inventory. Public banks are further limited geographically in their collection sites due to the need to employ a skilled cord blood collection technician in an associated hospital to ensure the quality of collections. This results in lower supply and reduced demographic diversity.
Private banks offer families the option of banking a child's cord blood for exclusive family use for an average collection and annual storage fee of $1750 and $125, respectively. However, the market is saturated, and the low cell-yield of collection makes private banking an expensive, low value option. Excluding emerging therapies, the chances of a child utilizing cord blood by age 10 is 1 in 5,000.
It would therefore be advantageous to provide a system and method for collecting cord blood that is easy to use and maximizes the cell yield in collected samples.